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Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors
Sponsor: VA Office of Research and Development
Summary
The continuing increase in prevalence of obesity in older adults including many older Veterans has become a major health concern. The clinical trial will test the central hypothesis that a multicomponent intervention consisting of lifestyle therapy (diet-induced weight loss and exercise training) plus metformin will be the most effective strategy for reversing sarcopenic obesity and frailty in older Veterans with obesity.
Official title: Lifestyle Intervention Plus Metformin to Treat Frailty in Older Veterans With Obesity
Key Details
Gender
All
Age Range
65 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
114
Start Date
2021-05-14
Completion Date
2025-07-31
Last Updated
2026-09-14
Healthy Volunteers
Yes
Conditions
Interventions
Lifestyle therapy
Weight management program, in which participants are prescribed a balanced diet that provides and energy deficit of 500 to 750 kcal per day to induced \~10% weight loss plus Supervised combined aerobic and resistance exercise training three times weekly
Metformin Hydrochloride
Given orally starting at 500 mg (one tablet) taken orally once a day with meals. After a week, the dose of metformin will be increased to 1000 mg (two tablets) daily. After another week, the dose of metformin will be increased to 1500 mg (three tablets) daily.
Placebo
Given orally starting at 500 mg (one tablet) taken orally once a day with meals. After a week, the dose of placebo will be increased to 1000 mg (two tablets) daily. After another week, the dose of placebo will be increased to 1500 mg (three tablets) daily.
Healthy Lifestyle
Group educational sessions that focus on healthy diet, exercise, and social support once a month
Locations (1)
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States